FDA Regulation of Mobile Health Technologies

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Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the New England Journal of Medicine on FDA regulation of new mobile health technologies. From the article:

Medicine may stand at the cusp of a mobile transformation. Mobile health, or “mHealth,” is the use of portable devices such as smartphones and tablets for medical purposes, including diagnosis, treatment, or support of general health and well-being. Users can interface with mobile devices through software applications (“apps”) that typically gather input from interactive questionnaires, separate medical devices connected to the mobile device, or functionalities of the device itself, such as its camera, motion sensor, or microphone. Apps may even process these data with the use of medical algorithms or calculators to generate customized diagnoses and treatment recommendations. Mobile devices make it possible to collect more granular patient data than can be collected from devices that are typically used in hospitals or physicians' offices. The experiences of a single patient can then be measured against large data sets to provide timely recommendations about managing both acute symptoms and chronic conditions.

To give but a few examples: One app allows users who have diabetes to plug glucometers into their iPhones as it tracks insulin doses and sends alerts for abnormally high or low blood sugar levels. Another app allows patients to use their smartphones to record electrocardiograms, using a single lead that snaps to the back of the phone. Users can hold the phone against their chests, record cardiac events, and transmit results to their cardiologists. An imaging app allows users to analyze diagnostic images in multiple modalities, including positron-emission tomography, computed tomography, magnetic resonance imaging, and ultrasonography. An even greater number of mHealth products perform health-management functions, such as medication reminders and symptom checkers, or administrative functions, such as patient scheduling and billing.

The volume and variety of mHealth products are already immense and defy any strict taxonomy. More than 97,000 mHealth apps were available as of March 2013, according to one estimate.8 The number of mHealth apps, downloads, and users almost doubles every year. Some observers predict that by 2018 there could be 1.7 billion mHealth users worldwide. Thus, mHealth technologies could have a profound effect on patient care.

However, mHealth has also become a challenge for the Food and Drug Administration (FDA), the regulator responsible for ensuring that medical devices are safe and effective. The FDA's oversight of mHealth devices has been controversial to members of Congress and industry, who worry that “applying a complex regulatory framework could inhibit future growth and innovation in this promising market.” But such oversight has become increasingly important. A bewildering array of mHealth products can make it difficult for individual patients or physicians to evaluate their quality or utility. In recent years, a number of bills have been proposed in Congress to change FDA jurisdiction over mHealth products, and in April 2014, a key federal advisory committee laid out its recommendations for regulating mHealth and other health-information technologies. With momentum toward legislation building, this article focuses on the public health benefits and risks of mHealth devices under FDA jurisdiction and considers how to best use the FDA's authority.